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This double-blind randomized controlled clinical trial aimed to investigate the effect of whitening dentifrices on the clinical efficiency of in-office tooth bleaching procedures.
Sixty-three eligible participants (29 males and 34 females, mean age 26.1 years) with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different dentifrices used in this clinical trial: Crest Total (regular dentifrice) for group C, Crest 3D Whitening (conventional whitening dentifrice) for group CW, and Close Up White Now (whitening dentifrice containing blue covarine) for group CU. All participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The participants will be instructed to use only the provided dentifrices and toothbrushes to brush their teeth twice daily over a 4-week period. Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4), and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and whiteness index (W) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Whitening dentifrice | Experimental | in-office bleaching with the conventional whitening dentifrice |
|
| Whitening dentifrice containing blue covarine | Experimental | in-office bleaching with the whitening dentifrice containing blue covarine |
|
| Regular dentifrice | Experimental | in-office bleaching with the regular dentifrice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in-office bleaching with the conventional whitening dentifrice | Combination Product | Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the conventional whitening dentifrice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tooth colour | Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0). The color alteration after each session will be given by the differences between the values obtained at the sessions and the baseline (∆E). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tooth whiteness | The whiteness index will be registered at the sessions and the baseline. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Yu | Fujian Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University | Fuzhou | Fujian | 350004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38303586 | Derived | Jiang NW, Cheng YL, Huang HL, Zhong BJ, Bi W, Yu H. Correlation between patient satisfaction and color changes after tooth bleaching. J Esthet Restor Dent. 2024 Mar;36(3):437-444. doi: 10.1111/jerd.13200. Epub 2024 Feb 1. |
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factorial assignment
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|
| in-office bleaching with the whitening dentifrice containing blue covarine | Combination Product | Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the whitening dentifrice containing blue covarine. |
|
| in-office bleaching with the regular dentifrice | Combination Product | Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the regular dentifrice. |
|
| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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